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Schedule M (GMP)
What it is
India's statutory Good Manufacturing Practices standard under the Drugs and Cosmetics Act, 1940. The revised Schedule M notified Dec 2023 aligned Indian GMP with WHO-GMP, PIC/S and ICH Q10, mandating quality systems, risk management, lifecycle validation and product quality review
Large firms complied by Jun 2024; MSMEs were given to 31 Dec 2025, with risk-based inspections from Jan 2026
Impact on industries
- Raises the floor on domestic drug quality and narrows the gap between export-grade plants and units still running on 2001-era rules
- Consolidation tailwind for compliant players and contract manufacturers, who absorb volumes released by units that exit
- Out of reach for much of the base - of ~8,500 MSME units only ~1,700 filed upgrade plans, against a cost of Rs 2 cr minimum to Rs 10-15 cr per facility
- These units make ~70% of generic output, so closures carry supply and jobs risk; industry sought a Dec 2026 extension but DCGI has signalled none